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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05003674




Registration number
NCT05003674
Ethics application status
Date submitted
21/07/2021
Date registered
12/08/2021
Date last updated
11/09/2023

Titles & IDs
Public title
A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Scientific title
A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients
Secondary ID [1] 0 0
AI5782
Universal Trial Number (UTN)
Trial acronym
FOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Impairment 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Focused stimulation strategy
Treatment: Devices - ACE stimulation strategy

Experimental: Adults cochlear implant recipients receiving alternative stimulation strategy - ACE strategy, 8 maxima, alternative mode

Active Comparator: Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy. - ACE strategy, 8 maxima, monopolar mode.


Treatment: Devices: Focused stimulation strategy
Investigational focused stimulation strategy

Treatment: Devices: ACE stimulation strategy
Standard of care stimulation strategy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)
Timepoint [1] 0 0
7 months

Eligibility
Key inclusion criteria
1. Adults 18 years of age or older.

2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array as
determined by the implanting centre.

3. English spoken as a primary language.

4. Willingness to comply with all investigational requirements.

5. Willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous or existing cochlear-implant recipient.

2. Evidence of severe or greater sensorineural hearing loss prior to five years of age.

3. Open-set pre-operative word score > 70% in the contralateral ear.

4. Duration of severe to profound hearing loss > 20 years in the ear to be implanted.

5. Adults with functional acoustic hearing in the ear to be implanted who desire to use
an acoustic component in the implanted ear.

6. Ossification or other cochlear anomaly that might prevent complete insertion of the
electrode array.

7. Hearing loss of neural or central origin.

8. Medical or psychological conditions that would contraindicate undergoing surgery.

9. Women who are pregnant.

10. Additional handicaps that would prevent or restrict participation in the audiological
evaluations.

11. Unrealistic expectations on the part of the subject regarding the possible benefits,
risks, and limitations that are inherent to the surgical procedure and prosthetic
device.

12. Inability or unwillingness to use a hand-held device to control the sound processor
and to collect test and survey data.

13. Unable or unwilling to comply with the requirements of the clinical investigation as
determined by the Investigator.

14. Investigator site personnel directly affiliated with this study and/or their immediate
families; immediate family is defined as a spouse, parent, child, or sibling.

15. Cochlear employees or employees of Contract Research Organisations or contractors
engaged by Cochlear for the purposes of this investigation.

16. Currently participating, or participated within the last 30 days, in another
interventional clinical investigation/trial involving an investigational drug or
device.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
NextSense - Deakin - Deakin
Recruitment hospital [2] 0 0
NextSense - Broadmeadow - Broadmeadow
Recruitment hospital [3] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [4] 0 0
St Vincent's Private Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
2600 - Deakin
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This feasibility study is designed to explore several facets of hearing performance that may
show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation
within a group of adult cochlear-implant recipients. Measures of speech recognition, music
appreciation, listening effort, quality of life, and real-world assessments will be gathered
to determine the most promising benefits for further examination.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05003674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruth English
Address 0 0
Country 0 0
Phone 0 0
+61438745639
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05003674